InfoCons Consumer Protection informs you – Talmanco – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet . See section 4.

ℹ️ 1. What Talmanco is and what it is used for

Talmanco contains the active substance tadalafil.

Talmanco is a treatment for pulmonary arterial hypertension in adults and in children aged 2 years and above .

It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical acti vity.

⚠️ 2. What you need to know before you take Talmanco

Do not take Talmanco

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.

Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.

• if you have ever had loss of vision – a condition described as “stroke of the eye” (non -arteritic anterior isc hemic optic neuropathy – NAION)
• if you have had a he art attack in the last 3 months
• if you have low blood pressure
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Talmanco , have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you have:

• any heart problems other than your pulmonary hypertension
• problems with your blood pressure 28 – any hereditary eye disease
• an abnormality of red blood cells (sickle cell anaemia)
• cancer of the bone marrow (multiple myeloma)
• cancer of the blood cells (leukaemia)
• any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours
• a serious liver problem
• a serious kidney problem If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking Talmanco, stop taking Talmanco and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.

Children and adolescents

This medicine is not recommended for the treatment of pulmonary hypertension in children under 2 years of age because it has not been studied in this age group .

Other medicines and Talmanco

Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines .

Do NOT take these tablets if you are already taking nitrates.

Some medicines may be affected by Talmanco or they may affect how well Talmanco will work. Tell your doctor or pharmacist if you are already taking:

• bosentan (another treatment for pulmonary a rterial hypertension)
• nitrates (for chest pain)
• alpha blockers used to treat high bloo d pressure or prostate problems
• riociguat
• rifampicin (to treat bacterial infections)
• ketoconazole tablets (to treat fungal infections)
• ritonavir (for HIV treatment)
• tablets for erectile dysf unction (PDE5 inhibitors) Talmanco with alcohol Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Talmanco , avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.

Pregnancy , breast -feeding and fertility If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take this medicine when pregnant, unless it is strictly necessary and you have discussed this with your doctor.

Do not breast -feed while taking these tablets as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast -feeding.

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines

Dizziness has been reported. Check carefully how you react to th is medicine before driving or using any machinery.

29 Talmanco contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicin e.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium – free’.

💊 3. How to take Talmanco

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Talmanco is supplied as a 20 mg tablet. Swallow the tablet(s) whole with a drink of water. The tablet(s) can be taken with or without food.

Pulmonary arterial hypertension in adults The usual dose is two 20 mg tablets taken once a day. You should take both tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.

Pulmonary arterial hypertension in children (age 2 years and above) weighing at least 40 kg The recommended dose is two 20 mg tablets taken once a day. Both tablets should be taken at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.

Pulmonary arterial hypertension in children (age 2 years and above) weighing less than 40 kg The recommended dose is one 20 mg tablet taken once a day. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take 10 mg once per day.

Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.

If you take more Talmanco than you should

If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you. You may experience any of the side effects described in section 4.

If you forget to take Talmanco

Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Talmanco

Do not stop taking your tablets, unless advised otherwise by your doctor.

If you have any further questions on the use of this medicine , ask your doctor or pharmacist .

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

Common (may affect up to 1 in 10 people)

• allergic reactions including skin rashes.
• chest pain – do not use nitrates, but seek immediate medical assistance .

Uncommon (may affect up to 1 in 100 people)

• priapism, a prolonged and possibly painful erection after taking this medicine. If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.

Rare (may affect up to 1 in 1,000 people)

• sudden loss of vision.

Not known (frequency cannot be estimated from the available data)

• distorted, dimmed, blurred central vision or sudden decrease of vision.

Other side effects have been reported

Very Common (may affect more than 1 in 10 people)

• headache .
• flushing, nasal and sinus congestion (blocked nose) .
• nausea, indigestion (including abdominal pain or discomfort).
• muscle aches, back pain and pain in the extremity (including limb discomfort) .

Common (may affect up to 1 in 10 people)

• blurred vision.
• low blood pressure.
• nosebleed.
• vomiting.
• increased or abnormal uterine bleeding.
• swelling of the face.
• acid reflux.
• migraine.
• irregular heartbeat.
• fainting.

Uncommon (may affect up to 1 in 100 people)

• seizures.
• passing memory loss.
• hives.
• excessive sweating.
• penile bleeding.
• presence of blood in semen and/or urine.
• high blood pressure.
• fast heart rate.
• sudden cardiac death.
• ringing in the ears.

PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely (may affect up to 1 in 1,000 people) reported:

• Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat. Sudden decrease or loss of hearing has also been reported.

Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction.

These events were not seen in clinical trials for pulmonary arterial hypertension and therefore frequency is not known (frequency cannot be estimated from the available data) :

• swelling of the eyelids, eye pain, red eyes, heart attack and stroke.

31 Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:

• distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to tadalafil.

Reporting of side effects

If you get any side effects , talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Talmanco

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP” .

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Talmanco contains

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients in the tablet core are povidone, sodium laurilsulfate, poloxamer 188,

anhydrous lactose (see section 2 ‘Talmanco contains lactose and sodium ’), microcrystalline cellulose (PH 101), croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.

The film -coating contains lactose monohydrate (see section 2 ‘Talmanco contains l actose and sodium ’), hypromellose (E464) , titanium dioxide (E171) and triacetin.

What Talmanco looks like and contents of the pack

This medicine is a white, film -coated, round, biconvex, bevelled edge tablet marked with ‘M’ on one side of the tablet and ‘TA20’ on the other side.

This medicine is available in blister packs containing 28 or 56 tablets and in perforat ed unit dose blister packs containing 28 x 1 or 56 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN Ireland 32 Manufacturer s McDermott Laboratories L imited t/a Gerard Laboratories t/a Mylan Dublin 35/36 Baldoyle Industrial Estate Grange Road , Dublin 13 Ireland Mylan Hungary Kft Mylan utca 1 Komárom, 2900 Hungary Mylan Germany GmbH Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 Bad Homburg v. d. Hoehe Hessen, 61352, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Viatris Tél/Tel: +32 (0)2 658 61 00 Lietuva Viatris UAB Tel: +370 5 205 1288 България Майлан ЕООД Teл.: +359 2 44 55400 Luxembourg/Luxemburg Viatris Tél/Tel: + 32 (0)2 658 61 00 (Belgique/Belgien ) Česká republika Viatris CZ s.r.o.

Tel: +420 222 004 400 Magyarország Viatris Healthcare Kft.

Tel.: +36 1 465 2100 Danmark Viatris ApS Tlf: + 45 28 11 69 32 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 Deutschland Viatris Healthcare GmbH Tel: + 49 800 0700 800 Nederland Mylan BV Tel: + 31 (0)20 426 3300 Eesti Viatris OÜ Tel: +372 6363 052 Norge Viatris AS Tlf: +47 66 75 33 00 Ελλάδα Viatris Hellas Ltd Τηλ: +30 210 0 100 002 Österreich Viatris Austria GmbH Tel: +43 1 86390 España Viatris Pharmaceuticals, S.L .

Tel: +34 900 102 712 Polska Viatris Healthcare Sp. z o.o.

Tel: + 48 22 546 64 00 France Substipharm Tél: +33 1 43181300 Portugal Mylan, Lda.

Tel: + 351 214 127 200 33 Hrvatska Viatris Hrvatska d.o.o.

Tel: +385 1 23 50 599 România BGP Products SRL Tel: +40 372 579 000 Ireland Viatris Limited Tel: +353 1 8711600 Slovenija Viatris d.o.o.

Tel: +386 1 23 6 31 8 0 Ísland Icepharma hf .

Sími: +354 540 8000 Slovenská republika Viatris Slovakia s.r.o.

Tel: +421 2 32 199 100 Italia Viatris Italia S.r.l .

Tel: + 39 (0) 2 612 46921 Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9555 Κύπρος GPA Pharmaceuticals Ltd Τηλ: +357 22863100 Sverige Viatris AB Tel: +46 (0) 8 630 19 00 Latvija Viatris SIA Tel: +371 676 055 80 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600 This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Talmanco (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1153).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.